Product Details

Simponi

Golimumab
50 mg/0.5 mL
Solution for Subcutaneous Injection
Single-Use 0.5-mL Pre-Filled Syringe (Preservative-Free)

DIN/PIN/NPN

02324776

Manufacturer

Janssen Inc.

Formulary Listing Date

2016-01-28

Unit Price

1555.1700

Amount MOH Pays

1555.1700

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

92:36:00 Disease-Modifying Antirheumatic Agents

Therapeutic Note

NO

ATC Code

L04AB06

Interchangeable Products

NO

LU Clinical Criteria

NO

EAP Criteria

Therapeutic Class	Reimbursement Criteria
Rheumatoid Arthritis	Adalimumab – see Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars Dosage Form/Strength: 40 mg/0.8mL prefilled syringe, 40 mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Anakinra Brand(s): Kineret Dosage Form/Strength: 100 mg /0.67 mL subcutaneous injection Certolizumab pegol Brand(s): Cimzia Dosage Form/Strength: 200 mg/mL prefilled syringe and autoinjector Etanercept – see Formulary for funded biosimilars Brand(s): Enbrel Dosage Form/Strength: 25 mg and/or 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options Golimumab Brand(s): Simponi Dosage Form/Strength: 50 mg/0.5 mL prefilled syringe and autoinjector Infliximab – see Formulary for funded biosimilars Brand(s): Remicade Dosage Form/Strength: 100 mg/vial intravenous infusion Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document) For the treatment of rheumatoid arthritis in patients who have: Severe active disease (≥ 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) despite the optimal use of various formulary disease-modifying anti-rheumatic drugs (DMARDs). Optimal use of DMARDs include: Methotrexate (20 mg/week) for at least 3 months and leflunomide (20 mg/day) for at least 3 months in addition to an adequate trial (3 months) of at least one combination of DMARDs; OR Methotrexate (20 mg/week) for at least 3 months and leflunomide in combination with methotrexate for at least 3 months. Note: If the patient could not receive adequate trial(s) of methotrexate and/or leflunomide due to contraindication(s) or intolerance(s), the nature of contraindication(s) or intolerance(s) must be provided along with details of trials of other DMARDs or clear rationale why other DMARDs cannot be considered. OR Methotrexate (20mg/week), sulfasalazine (2 GM/day) and hydroxychloroquine (400mg/day)* for at least 3 months. If the patient could not receive an adequate trial of methotrexate, sulfasalazine and hydroxychloroquine due to intolerance, then the above DMARD trial criteria must be met. Hydroxychloroquine is based by weight up to 400 mg per day Duration of Approval:* 1 Year Renewal will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of rheumatoid arthritis are as follows: Adalimumab 40mg every two weeks Anakinra 100mg per day Certolizumab pegol 400mg at 0, 2 and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks. For maintenance dosing, 400mg every 4 weeks may be considered Etanercept 25mg twice weekly or 50mg once weekly Golimumab 50mg once a month Infliximab 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year Duration of Approval: - First Renewal: 1 Year - Subsequent Renewals: 5 Years EAP Drug Request Form: Standard Form for EAP Drug Requests
Ankylosing Spondylitis Drugs	Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars Dosage Form/Strength: 40mg/0.8mL prefilled syringe, 40mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Certolizumab Brand(s): Cimzia Dosage Form/Strength: 200 mg/mL prefilled syringe and autoinjector Etanercept – See Formulary for funded biosimilars Brand(s): Enbrel and formulary listed biosimilars Dosage Form/Strength: 25mg/vial and 50mg prefilled syringe for subcutaneous injection Golimumab Brand(s): Simponi Dosage Form/Strength: 50 mg/0.5 ml prefilled syringe and autoinjector Infliximab- See Formulary for funded biosimilars Brand(s): Remicade and formulary listed biosimilars Dosage Form/Strength: 100mg/10mL intravenous infusion Secukinumab Brand(s): Cosentyx Dosage Form/Strength: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document) For the treatment of ankylosing spondylitis (AS) OR psoriatic spondylitis (PS) in patients who have severe active disease with: Age of disease onset 50 years of age or younger; AND Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND BASDAI score of ≥ 4 for at least 4 weeks while on standard therapy; AND A list of current concomitant medications related to the AS/PS, including pain medications (if relevant) with dosing regimens provided. NSAIDs include coxibs; use of DMARDS instead of NSAIDs not acceptable. The information submitted with the request must include the following: A list of current concomitant medications related to the AS/PS, including pain medications (if relevant). Please include dosing regimens. Details of review of radiographic reports for severe active disease. o X-ray or CT scan report stating the presence of “SI joint fusion” or “SI joint erosion” OR o MRI report stating the presence of “inflammation” or “edema” of the SI joint o Actual radiographic reports must be submitted with the request. If the radiographic reports do not specify the above, the request will be reviewed by external medical experts. Additional information that should be provided if applicable: Schober measurement and chest expansion measurement Evidence of restricted spinal mobility If the patient has AS/PS with predominantly peripheral joint involvement, additional information pertaining to trials of DMARDs must be provided, and these requests will be reviewed by external medical experts. Duration of Approval:* 1 year Renewal will be considered for patients with objective evidence of at least a 50% reduction in BASDAI score or ≥ 2 absolute point reduction in BASDAI score. Please provide an update on concomitant medications for AS/PS and whether there has been a reduction in pain medication for AS/PS since initiating the biologic (if applicable). For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of AS/PS are: Adalimumab 40 mg every two weeks Certolizumab 400mg at 0, 2, and 4 weeks followed by maintenance therapy of 200 mg every 2 weeks or 400 mg every 4 weeks. Etanercept 25 mg twice weekly or 50 mg once weekly Golimumab 50mg once a month Infliximab 3-5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks Secukinumab 150 mg SC at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. Duration of Approval: First renewal: 1 year; Second and subsequent renewals: 5 years EAP Drug Request Form: Standard Form for EAP Drug Requests
Inflammatory Bowel Diseases	Golimumab Brand(s): Simponi Dosage Form/Strength: 50 mg/0.5mL Pre-Filled Syringe or Auto-Injector, 100 mg/ mL Pre-filled Syringe or Auto-Injector For the treatment of ulcerative colitis disease in patients who meet the following criteria: Induction Criteria: Mild disease: Mayo score below 6 AND Patients with mild disease will be considered on a case-by-case basis BUT submission must include the rationale for coverage Moderate disease: Mayo score between 6 and 10 (inclusive) AND Endoscopic subscore of 2 AND Failed 2 weeks of oral prednisone ≥ 40mg (or a 1-week course of IV equivalent) but the prednisone dose cannot be tapered despite 3 months azathioprine (AZA)/6- mercaptopurine(6MP) (or where the use of immunosuppressants is contraindicated) OR Stabilized with 2 weeks of oral prednisone ≥ 40mg (or a 1-week course of IV equivalent) but the prednisone dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated) Severe disease: Mayo score > 10 AND Endoscopy subscore of ≥ 2 AND Failed 2 weeks of oral prednisone ≥ 40mg (or 1 week IV equivalent) OR Stabilized with 2 weeks oral prednisone ≥ 40mg (or 1 week of IV equivalent) but the prednisone dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated) Initial Approval: 6 months at 200 mg initially administered at week 0, followed by 100mg at week 2, and then 50 mg every 4 weeks thereafter. The maintenance dose of 100mg every 4 weeks can be considered at the discretion of the treating physician Maintenance Criteria: After 4 loading doses of Simponi: Mayo score below 6 AND 50% reduction in prednisone from the starting dose Approval: 6 months at 50 mg or 100 mg every 4 weeks If patient is completely off steroids. Approval: 12 months at 50 mg or 100 mg every 4 weeks. Subsequent renewals: Mayo score below 6; AND Must be off steroids (Patients who remain on steroids will be considered on a case-by-case basis) Approval: 2 years at 50 mg or 100 mg every 4 weeks. Duration of Approval: - Renewal duration: 6 months to 1 year (Pending if patient continues on steroids.) - Second and subsequent renewal: 2 years for those off steroids EAP Drug Request Form: Standard Form for EAP Drug Requests
Psoriatic Arthritis Treatments	Adalimumab – See Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars Dosage Form/Strength: 40 mg/0.8 mL prefilled syringe, 40 mg/0.8mL and 20 mg/0.2 mL prefilled pens for subcutaneous injection Certolizumab Brand(s): Cimzia Dosage Form/Strength: 200 mg/mL prefilled syringe and autoinjector Etanercept – see Formulary for funded biosimilars Brand(s): Enbrel and formulary listed biosimilars Dosage Form/Strength: 25 mg/vial and 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options Golimumab Brand(s): Simponi Dosage Form/Strength: 50 mg/0.5 ml prefilled syringe and autoinjector Secukinumab Brand(s): Cosentyx Dosage Form/Strength: 150 mg/mL prefilled syringe and 150 mg/mL prefilled pen Originator biologics (e.g., Enbrel®, Humira®, Remicade®, and Rituxan®) with a provincially funded biosimilar are only considered for provincial funding in patients who are treatment experienced and stable on the reference biologic or those with existing EAP approvals. Prescribers should refer to the ODB formulary for biosimilars and their funded conditions. It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on a originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, may be expected to be provided ongoing access of the reference biologic through the patient support program or to use a biosimilar upon meeting specified criteria. The Ministry will only consider funding of Originator biologics with a funded biosimilar version in those who are treatment experienced and stabilized on the product prior to transitioning to the ODB program or in patients with an existing EAP approval. Refer to the Executive Officer Communications on the Ministry website for Frequently asked questions and notifications of funded biosimilars at http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions (see below). In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 of this document) For the treatment of psoriatic arthritis in patients who have: Severe active disease (≥ 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20 mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20 mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required. Details of contraindications and intolerances must also be provided. Duration of Approval of initials: 1 Year Renewal will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Duration of Approval of first renewal: 1 Year The planned dosing regimen for the requested biologic should be provided. The recommended doses for the treatment of psoriatic arthritis are as follows: Adalimumab 40mg every two weeks Certolizumab 400 mg at week 0, 2, 4 then maintenance doses of 200 mg every 2 weeks or 400 mg every 4weeks Etanercept 25 mg twice weekly or 50mg once weekly Golimumab 50 mg once a month Secukinumab 150mg SC at weeks 0, 1, 2, and 3 followed by monthly maintenance dosing starting at week 4. If a patient is an anti-TNF-alpha inadequate responder and continues to have active psoriatic arthritis, consider using the 300 mg SC dose. For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis (i.e., 300 mg SC at weeks 0, 1, 2, and 3, followed by monthly maintenance dosing starting at week 4) Duration of Approval of second and subsequent renewals: 5 years EAP Drug Request Form: Standard Form for EAP Drug Requests

Product Monograph